cobas® Cdiff Test

Answers that help stop the threat of infection

Addressing one of the most common healthcare-associated infections

 

The continued rise in frequency and severity of Clostridium difficile (C. difficile)-associated disease prompted a need for rapid and reliable C. difficile testing, particularly in vulnerable elderly populations.

 

cobas® Cdiff& on the cobas® 4800 System combines high assay sensitivity with rapid turnaround time and a minimum number of pre-analytic steps. Accurate and timely detection of C. difficile in patient stool samples facilitates earlier intervention for more effective infection control and transmission prevention.

The performance that clinical confidence demands

cobas® Cdiff demonstrated superior performance compared to direct culture cytotoxicity testing in a study of >1,200 samples.

 

  • Selective detection of a specific difficile toxin gene directly from uniformed stool samples using real-time PCR technology
  • Detection of a broad array of toxinotypes and ribotypes
  • Generate robust results automatically, using patented, state-of-the-art algorithms

Make every sample count

When compared to a CE- and FDA-cleared NAAT, cobas® Cdiff had a 4x lower inhibition rate and a 2x lower total error rate. A lower inhibition rate means fewer repeat samples, less chances for error, and better patient care.

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Reduce hands-on time with the flexible, automated workflow

Accuracy delivered efficiently

 

The cobas® Cdiff Test requires only 3 simple steps for sample prep, minimizing sample handling.

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Less hands-on time means more walk-away time

The cobas® Cdiff Test requires up to 74% less hands-on time than competitor platforms.

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Run mixed batch assays

The cobas® 4800 System offers flexibility with parallel sample processing capabilities. cobas® Cdiff samples can be run with different tests and sample types in one run, including:

 

  • Stool (cobas® Cdiff)
  • Nasal (cobas® MRSA/SA)
  • Anogenital lesions (cobas® HSV 1 and 2)

Intended use

The cobas® Cdiff Test on the cobas® 4800 System is an automated, qualitative in vitro diagnostic test, that utilizes realtime polymerase chain reaction (PCR), for the direct detection of the toxin B (tcdB) gene of toxigenic Clostridium difficile in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The cobas® Cdiff Test is intended for use as an aid in the diagnosis of CDI in humans in conjunction with clinical and epidemiological risk factors.

CE-IVD marked.

This product is not registered as an in vitro diagnostic (IVD) in all countries; additional information may be available from your Roche sales representative

Registration status

CE-IVD marked

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.

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Related systems

Highly efficient, flexible workflows and a consolidated assay menu deliver confidence with every result. Automated PCR setup and analys is help make the most of your resources and reduce error.